The latest drug and device list approved worldwide in June

In June 2021, more than half of the year, the number of new drugs approved globally will increase

01

Global drug approval status

(1) Approval by the US FDA

Figure 1: Changes in the number of FDA drug approvals (a) from 2008 to 2021

Source: U.

As shown in Figure 1, as of July 2, 2021, the official website of the FDA disclosed that in June 2021, the FDA had completed 60 first drug approvals (not including provisional approval), of which 18 were NDA/BLA approved (not including provisional approval)

Table 1: List of NDA/BLA drugs approved by the FDA in June 2021

Source: U.

(2) EU EMA approval status

As of July 2, 2021, EMA has no recommended drugs for marketing in June 2021

Figure 2: Changes in the number of drugs recommended by the EMA for marketing (units) from 2012 to 2021

Source: Flint Creation Database

Note: The number of drugs recommended for listing: the number of drugs recommended for listing by CHMP (Committee for Medicinal Products for Human Use) with a positive opinion;

NAS quantity: the quantity of new active substance, sourced from the official website of EMA and annual reports

(3) NMPA approval status

As of July 1, 2021, NMPA disclosed that in June 2021, a total of 200 domestic first-registered drugs were approved

Achilles is the first CAR-T anti-cancer drug approved for marketing in China.

Imitenofovir tablets are China’s first original researched oral anti-hepatitis B virus (HBV) drug.

Donafinil tosylate tablets (Zepxen) is an innovative drug independently developed by China with independent intellectual property rights.

Saivotinib was jointly developed by Hutchison Medicine and AstraZeneca, and is the first domestically produced MET inhibitor

Table 2: List of approved Class 1 innovative drugs approved by NMPA

Source: State Drug Administration

(4) Consistency evaluation of generic drugs

As of July 1, 2021, the official website of CDE disclosed that there were 3,111 drug consistency evaluation acceptance numbers, and a total of 66 new acceptance numbers were accepted this month

At present, there are a total of 780 product specifications (165 varieties) of injection formulations that have passed the consistency evaluation products.

Figure 3: The consistency evaluation of generic drugs from January 2020 to June 2021

Changes in approved quantity (a)

Source: State Drug Administration

02

Global medical device approval status

(1) Approval by the US FDA

As of July 2, 2021, the FDA has approved a total of 184 510(k) route products in June 2021, including 13 Class I devices, 169 Class II devices, and 2 unclassified devices

After categorizing the 510(k) pre-market notification devices according to the medical professional use in the United States, it was found that the most approved types of products in June were general and plastic surgery devices, radiology devices, orthopedics devices, and general hospital and personal use categories.

Figure 4: Distribution of product types approved for marketing through the FDA 510(k) route in June 2021

Source: U.

Table 3: Devices approved by PMA for the first time in June 2021

Source: U.
S.
Food and Drug Administration

(2) Domestic approval

As of July 2, 2021, in June 2021, the State Administration has announced that 5 Class III medical devices have entered the green channel for innovation approval, as shown in Table 4
.

Table 4: Three types of innovative devices entering the green channel in June 2021

Source: National Medical Device Evaluation Center

As of July 2, 2021, in June 2021, the State Administration has announced that 3 innovative medical devices of Class III have been approved for listing, as shown in Table 5
.

Table 5: Innovative medical devices approved for marketing in June 2021

Source: National Medical Device Evaluation Center

As of July 2, 2021, in June 2021, the State Administration has approved a total of 155 Class III medical device products for the first registration, of which 118 are domestically produced and 37 are imported
.
This month, the provincial drug regulatory authorities approved a total of 821 domestic second-class medical device registrations and 1,139 first-class registered medical devices
.

Statistics show that affected by the epidemic, the number of in vitro diagnostic reagents is the largest, with a total of 881 items, accounting for 41.
65%
.
In addition to in-vitro diagnostic reagents, the top three approved registration categories are infusion, nursing and protective devices, clinical testing devices, and passive surgical devices
.

Table 6: Distribution of the number of approved and registered types of domestic and imported medical devices in June 2021

Source: National Medical Device Evaluation Center

From the perspective of geographical distribution, the three regions with the most approvals for the second and third categories of registered products in June were Hunan Province, Guangdong Province and Jiangsu Province
.

03

summary

The number of new drugs approved globally rose in June 2021, and the number of new drugs approved by the FDA this month was the highest in the first half of 2021
.
The development of domestic innovative drugs is accelerating, and more and more Class 1 new drugs are developed and marketed, and many of them are Class 1 new drugs independently developed by domestic pharmaceutical companies
.
With the implementation of the fifth batch of centralized procurement, the development of consistency evaluation is also proceeding steadily
.
There are more and more varieties that have been evaluated for consistency among the top 3 companies, and injections have also received more attention
.

In terms of medical devices, the FDA approved 1 PMA device for the first time.
This month, domestic medical device approvals focused on in vitro diagnostic reagents.
A total of 881 items were approved, accounting for 41.
65%
.
In addition, Apple’s mobile electrocardiogram atrial fibrillation reminder software (commonly known as ECG electrocardiogram) has been successfully approved in China
.